BEUDAMED
    8 results · 24ms · Sources: EU EUDAMED, US FDA

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    WAKO(TM) AUTOKIT CRP

    FDA 510(k)
    FDA Class 2 ·Immunology

    MOLTENO IMPLANT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MODEL 2030; 3 TMJ SURFACE COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·June 25, 2014

    ASR ACETABULAR IMPLANT 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 3, 2013

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·November 10, 2010

    Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.

    FDA Enforcement
    Class I ·Terminated·Cook Inc.·March 2, 2016

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021